PDA ANSI Standard 06-2025 Published in February 2025 to Guide Quality Culture Assessments

The PDA/ANSI Standard 06-2025, titled “Assessment of Quality Culture Guidance Documents, Models, and Tools,” was officially published in February 2025. Matt Cushing, Vice President of Quality and Science at Nelson Labs, and Susan J. Schniepp, a distinguished fellow at Regulatory Compliance Associates—a Nelson Labs company—provided insights into the standard’s development and its implications for quality culture assessments.

The document outlines comprehensive guidance on evaluating quality culture within organizations using established models and tools. It aims to provide a structured framework for assessing how effectively an organization fosters a culture that prioritizes quality in its operations. The publication represents a collaborative effort to address industry needs for standardized approaches to measuring and improving quality practices across various sectors.

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Source: GO-AI-ne1

Date: June 3, 2025

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Mark Chiang